Care China-Diabetes

Johnson & Johnson Medical, China1,603 enrolled

Overview

This multicenter, prospective, observational registry will assess efficacy and safety outcomes associated with percutaneous coronary intervention (PCI) with implantation of the CYPHER Select™+ Sirolimus-eluting Coronary Stents in Chinese diabetic patients with coronary artery disease in routine clinical practice.

The study objective is to assess the incidences of major adverse cardiovascular events (MACE; defined as a composite of clinically driven target-lesion revascularization, cardiac death, any myocardial infarction, and stent thrombosis) at 12-month follow-up, and of stent thrombosis at 1-day, and 1- and 12-month follow-up. Pre-specified analyses will be performed among patient subpopulations according to level of glycemic control (HbA1c level \< 6.5% or \> 6.5%); reference vessel diameter by quantitative coronary angiography (\< 2.5 mm and \> 2.5 mm); and stented length (8-18 mm; 23-33 mm; and \>33 mm). Quantitative coronary angiographic (QCA) analysis will be performed at the core lab of the China Cardiovascular Research Foundation for all pre- and post-index procedure angiograms and during the 12-month follow-up period for the pre- and post-reintervention procedures in those cases of clinically-driven PCI revascularization. Also, multivariable analyses will be conducted to investigate potential predictors of 12-month MACE rate in routine clinical practice. The registry will be conducted at about 45 centers in China, where the CYPHER Select™+ Sirolimus-eluting Coronary Stent is commercially available. Data will be collected on 2,500 diabetic patients treated with the CYPHER Select™ + Sirolimus-eluting Coronary Stent only. Primary outcome: MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months Secondary outcome: ARC (probable + definite) ST at 1-day, and 1 and 12 months

Study Type

OBSERVATIONAL

Enrollment

1,603

Conditions

Cardiovascular Disease Diabetes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients between the ages of 18 and 80 (inclusive) receiving CYPHER SELECT™+ Sirolimus-eluting Coronary Stent according to standard clinical practice when financially feasible * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site. * Patient has diagnosis of diabetes or is diagnosed with it before or during the index procedure hospitalization based on disease diagnosis criteria Exclusion Criteria: * Any contraindication to any of the following medications: aspirin, heparin, thienopyridines (clopidogrel/ticlopidine), stainless steel, contrast agents, or sirolimus * An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment * Cardiogenic shock * Terminal illness with life expectancy \<1 year * ST-segment elevation myocardial infarction within 7 days prior to the index procedure * Any patient who received coronary stent(s) within 1 year

Locations (46)

Outcomes

Primary Outcomes

MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months

Time frame: 12 months

Secondary Outcomes

ARC (probable + definite) ST at 1-day, and 1 and 12 months

Time frame: 12 months

Data from ClinicalTrials.gov

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Beijing Anzhen Hospital of the Capital University of Medical Science